St. Jude Amplatzer Atrial Septal Occluder Dangers | Belt, Bruner & Barnett

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Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder

Oct 24, 2013 | Defective Products

Medical devices, improperly manufactured and designed, that are allowed to bypass the standard pathway for testing and approval, may inadvertently cause extensive injury or death to the patient, says medical malpractice and product liability attorney Keith T. Belt.

The St. Jude Amplatzer Atrial Septal Occluder (ASO) is a cardiac implant device used in children and adults to treat an abnormal hole between the upper left and right chambers (atria) of the heart, known as an atrial septal defect (ASD). The metal device is put into place through a thin tube (catheter) inserted into a vein. This is considered a minimally invasive method for ASD closure and is an alternative to open heart surgery.

The Food and Drug Administration (FDA) is alerting healthcare providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery. According to published estimates, these events occur in approximately 1 to 3 of every 1,000 patients implanted with the Amplatzer ASO. As of March 31, 2013, there have been 234,103 Amplatzer ASO devices sold worldwide.

Tissue erosion caused by the Amplatzer ASO is rare, but can be life-threatening. Between 2002 and 2011, the FDA received more than 100 reports of erosions associated with the St. Jude Amplatzer ASO and during the same period, several medical journals contained articles reporting tissue erosion among patients implanted with this device.

The device rubbing against the wall of the heart can erode the tissue creating a hole. It can also lead to further scraping or erosion through tissue in the upper chambers (atria) of the heart, primarily in the top of the atria near the aorta. This scraping may also cause separate or simultaneous holes in the aortic root, potentially leading to blood building up in the sac surrounding the heart restricting its ability to work properly.

Immediate open heart surgery may then be necessary to remove the device, close the holes or other defects caused by erosion, and close the original defect the device was meant to treat less invasively. Tissue erosion can also cause fistulas – abnormal scar tissue that connects parts of the heart that were not previously connected. Fistulas are not life-threatening, but do require surgery for treatment and could result in congestive heart failure.

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